Medical device manufacturer, Boston Scientific, has issued a field safety notice concerning NephroMax High Pressure Nephrostomy Balloon Catheter and NephroMax High Pressure Nephrostomy Balloon Catheter Kit.
Boston Scientific is conducting a Recall Removal of six batches of the NephroMax High Pressure Nephrostomy Balloon Catheters and three batches of the NephroMax High Pressure Nephrostomy Balloon Catheter Kits (which are packaged with an Encore 26 Inflator). Boston Scientific has discovered that the product which is labeled to contain either a 30F x 20cm or a 24F x 17cm renal sheath may potentially contain the incorrect renal sheath size in the package. There have been five complaints received from a single batch for this issue where the product was labeled to contain a 30F x 20cm sheath but actually contained a 24F x 17cm sheath.
Boston Scientific is aware that customers may separate the kits and store the components individually. Therefore, the manufacturer advises users that when reviewing inventory, they should look for both the kit level and individual component level batch numbers. Furthermore, the manufacturer advises users to immediately discontinue use of and segregate affected products, and to return the affected product.
According to the local supplier, affected products were not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 31 May 2013